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The goal of this clinical trial is to verify that virtual reality is tolerably compatible with apathetic pathologies in patients and residents with major neurocognitive disorders. The main questions it aims to answer are:
There is not a comparison group: Researchers will compare the scores before and after the intervention: the participant will be his own control.
This study is a multicenter interventional exploratory study in two nursing homes and a geriatric long-term care service. Thirty patients will be included. They will be recruited from residents of the long-term care departments of two hospitals, and 4 nursing homes.
A pre- and post-intervention comparison will be made by assessing apathy using the apathy inventory and the neuropsychiatric inventory in the care team version. A comparison of participants' engagement will be carried out through ecological observation of the interventions. This will be objectivized by the Caregiver Interaction Behavior Scale (ECPAI) before the immersion program, and during the first and third virtual reality sessions. An ECPAI scale taken during a conventional animation prior to the program will establish a baseline state for the participant.
The main goal is to verify that virtual reality is tolerably compatible with apathetic pathologies in patients and residents with major neurocognitive disorders.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | The participant will benefit from three immersion sessions with the virtual reality headset, either individually or in a group session, accompanied by a team member trained in the use of the headset (psychomotrician, occupational therapist, doctor, psychologist, facilitator). At each session, the scale of observed emotions and the cybermalaise questionnaire will be completed (T1, T2, T3). At sessions 1 (T1) and 3 (T3), the investigator will administer the ECPAI behavior scale. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Casque Lumeen | Device | Participants will take part in virtual reality sessions via headset. They will benefit from a before/after evaluation, and a 3-week intervention where they will have 1 virtual reality session per week. |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerance of virtual reality sessions | No change in Simulator Sickness Questionnaire (SSQ), or maintenance of "none" and "slight" scores. There are 16 items, each item is rated with the scale from none, slight, moderate to severe. After some calculations you have 3 subscores : Computation of nausea (N), oculomotor r disturbance (O), disorientation (D), and total simulator sickness (TS) scores. | through study completion, an average of 6 months |
| Effectiveness of virtual reality sessions on apathy symptoms | Decrease in apathy scores on the Apathy Inventory (IA) (NPI). IA clinician assessment (0 to 4 score) has to take into account several factors: useful observation points, Patient history and social environment, personality, Information coming from the caregiver, Patient's responses to the clinical domains, autonomy. A score equal or upper to 4 is pathological. | through study completion, an average of 6 months |
| Effectiveness of virtual reality sessions on apathy symptoms | Decrease in apathy scores on the Neuropsychiatric Inventory (NPI), caregiver version. The NPI-ES is based on responses from a member of the healthcare team involved in the patient's care. Responses refer to behaviours that have been present over the past week or other well-defined during other well-defined periods (e.g. 1 month ago, or since the last assessment). Answers should be brief, and can be formulated as "yes" or "no". In clinical practice, the most relevant factor to consider is the frequency x severity score for each area (a score greater than 2 is pathological). | through study completion, an average of 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Security | no technical problems endangering the user during sessions, resulting in the session being stopped | through study completion, an average of 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joël Belmin | Contact | 0149594565 | j.belmin@aphp.fr | |
| Nathavy Um Din | Contact | 0149594568 | livinglab.psga@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maison de retraite la Passerelle | Recruiting | Larajasse | Rhône | 69590 | France |
Each co-investigator coordinates his or her inclusions with the principal investigator, and sends him or her the data collected via secure messaging. The co-investigator is responsible for collating all the data.
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| ID | Term |
|---|---|
| D019965 | Neurocognitive Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| Maison de retraite l'arc en ciel | Recruiting | Saint-Martin-en-Haut | Rhône | 69850 | France |
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| USLD Arcadie - CHU Rouen | Recruiting | Mont-Saint-Aignan | Seine Maritime | 76130 | France |
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| EHPAD d'Enghien | Active, not recruiting | Enghien-les-Bains | Val d'Oise | 95880 | France |
| EHPAD Louis Grassi | Active, not recruiting | Presles | Val d'Oise | 95590 | France |
| Hôpital Charles Foix | Recruiting | Ivry-sur-Seine | Val De Marne | 94200 | France |
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